Kornimate/medical-research-clean huggingface dataset:
pilot study of liposomal bupivacaine redosing in patients undergoing major gynecologic procedures

Conditions: Ovarian Cancer; Fibroids; Uterine Cancer

Summary: the purpose of this research study is to find out which type of transversus abdomens plane (tap) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

the purpose of this research study is to find out which type of tap block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications. an anesthesiologist participating on this study will describe the tap block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. tap blocks are one of the various methods of controlling your pain after surgery. they are typically placed with an anesthetic agent, such as bupivacaine. the u.s. food and drug administration (fda) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. although both medications, bupivacaine and liposomal bupivacaine are approved by the fda, there are only a few trials such as this one, in the united states, comparing the various types of tap blocks. no studies exist comparing the re-dosing of a tap block, as we will be doing in this study. currently, the standard of care after a gynecologic procedure may or may not include receiving a tap block. this was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. as per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. our study will not change your post-operative pain medication schedule or timing. it will only study the effectiveness of the tap block you get in controlling your pain. even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are fda-approved, the use of these drugs in this study is investigational.

Eligibility criteria:
inclusion criteria * age ≥ 18 years old * must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist exclusion criteria * history of chronic pain * history of opioid dependence * suspected or confirmed history of endometriosis * history of fibromyalgia * suspected or confirmed interstitial cystitis or painful bladder syndrome * history of or current opioid use prior to surgery * hypersensitivity to bupivacaine * severe hepatic or renal disease

Keywords: ovarian cancer fibroids uterine cancer transverse abdominis plane block tap block
the use of atropine 0.01% in the prevention and control of myopia (atom3)

Conditions: Myopia

Summary: study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

high risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Eligibility criteria:
inclusion criteria 1. one parent with myopia (\<-3d in at least one eye) 2. se +1.00d to -1.50d 3. astigmatism \< = 1.50d 4. distance vision logmar 0.2 or better in both eyes 5. intraocular pressure of not greater than 21 mmhg 6. no allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride exclusion criteria: 1. any eye or systemic disease that affect vision or refractive error 2. conditions where topical atropine contraindicated 3. previous use of atropine or pirenzepine 4. known past/current amblyopia or strabismus
simvastatin versus mta in pulpotomy of immature permanent molars

Conditions: Pulp Exposure, Dental

Summary: the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus mta in pulpotomy of immature permanent molars

the clinical and digital radiographic success of simvastatin versus mta in pulpotomy of immature permanent molars for the following patients which include: healthy children aged from 6 to 8 years who will be classified as class i or ii children according to the american society of anaesthesiologists (asa) will be included. children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.

Eligibility criteria:
inclusion criteria: * healthy children aged from 6 to 8 years * children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded. * deep carious lesions of the first permanent immature molars with signs \& symptoms of reversible pulpitis will be included * normal radiographic findings and immature roots
gelad chemotherapy and sandwiched radiotherapy in the treatment of stage ie/iie natural killer/t-cell lymphoma

Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type

Summary: the purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (gelad) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage ie/iie extranodal natural killer/t-cell lymphoma, nasal type.

extranodal natural killer/t-cell lymphoma (enktcl), nasal type, is a rare subtype of non-hodgkin lymphoma (nhl) with relatively high incidence in china. radiotherapy alone for stage ie/iie diseases has good response rate but with high relapse rates, ranging from 20-50%. the combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage ie/iie diseases. but the optimal treatment schedule has not been established. this study is designed with two cycles gelad chemotherapy, followed by 50-56gy radiotherapy, and completed with additional two cycles gelad chemotherapy. the efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage ie/iie enktcl will be measured.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of extranodal natural killer/t-cell lymphoma, nasal type, previously untreated * eastern cooperative oncology group (ecog ) performance status 0\~3 * stage ie to iie disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, waldeyer's ring, or oral cavity. * preserved organ functions for: absolute neutrophil counter (anc)\>1.0×109/l, platelet\>50×109/l, hemoglobin\>80g/l, total bilirubin (tbil)\<2×uln, alanine transaminase (alt)\<2×uln, serum creatinine\<1.5×uln，fibrinogen≥1.0g/l, lvef≥50% * no history of chemotherapy or radiotherapy. * signed informed consented exclusion criteria: * concurrent cancers need surgery or chemotherapy within 6 months. * significant complications: lvef≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis. * mental disorders. * pregnant or lactation * hiv, hepatitis virus c (hcv), or active hepatitis virus b (hbv) infection with hbv dna≥105 copies/ml. * history of pancreatitis * known history for grade 3/4 allergy to the drugs in chemotherapy regimen. * enrolled in other trial treatment
lxrs, cholesterol metabolism and uterine dystocia

Conditions: Uterine Inertia; Dystocia

Summary: despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. this study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (snps) in the genes coding for the lxrs.


Eligibility criteria:
inclusion criteria: * patients undergoing c-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters) * the child is alive * the child does not have apriori known malformations that could interfere with a vaginal birth * foetus in cephalic position * full term pregnancy (\>= 37 weeks of amenorrhea) * single birth * patient has signed consent * patient is affiliated with a social security system exclusion criteria: * vaginal birth * programmed c-section * c-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process * multiple pregnancy * the child is in a breech position * premature birth (\<37 weeks amenorrhea) * in utero fetal death * fetal malformation known before birth that could interfere with a vaginal birth * non french-speaking patient (impossible to correctly inform the patient) * patient under guardianship
rct alb for sa cysticercosis

Conditions: Subarachnoid Cysticercosis

Summary: this study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named taenia solium. subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. this study will determine if two months of albendazole (abz) therapy is better than one-month. the study will last 3 years.

this is a randomized, double blind comparison of two lengths of albendazole thereapy for subarachnoid cysticercosis. it will enroll 120 individuals, male and female age 18 to 65, and diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named taenia solium. subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. this study will determine if two months of albendazole (abz) therapy is better than one-month. the study will last 3 years.

Eligibility criteria:
inclusion criteria: * male or female individuals between 18-65 year of age with a diagnosis of basal subarachnoid cysticercosis, based on mri and confirmed by serological test. * willingness to accomplish the two weeks minimal hospitalization required. * female of child-bearing potential willing to use an adequate method of contraception including implants, injectables, combined oral contraceptives, effective intrauterine devices, sexual abstinence, or vasectomized partner while participating in the study. * patients with normal laboratory values for hemoglobin, platelet counts, total white blood cells, glucose, creatinine, bilirubin, alt, ast, and electrolytes. * negative fecal exam for taenia eggs. exclusion criteria: * previous therapy with albendazole (does not include patients who received single-dose 400 mg abz for intestinal parasites), or praziquantel. * pulmonary tuberculosis evidenced by a positive chest x-ray and positive sputum smears. * pre-existing diagnosis of diabetes * systemic disease other than ncc that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases. identification of systemic diseases will be left to the discretion of each site pi. * patients in unstable condition or with severe intracranial hypertension (ich). definition of severe ich for this study would be the presence of headaches, nausea, and vomiting and papilledema at fundoscopic examination (all of them). patients in this category can be considered for entrance into the study only after treatment of ich by ventricle-peritoneal shunting. patients with ct findings compatible with intracranial hypertension will have neurosurgical evaluation (by non study personal) before study entry. * pregnancy * history of hypersensitivity to albendazole * concurrent treatment with praziquantel, cimetidine or teophylline. * chronic alcohol or drug abuse

Keywords: albenza, subarachnoid cysticercosis
assessment of long-term out-of-hospital treatment of patients with proximal deep vein thrombosis (dvt) using low-molecular-weight heparin (lmwh) versus lmwh followed by warfarin

Conditions: Thrombosis; Thromboembolism; Venous Thrombosis

Summary: the purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.

two studies demonstrated that out-of-hospital low-molecular-weight heparin given by twice daily subcutaneous injection without laboratory monitoring was as effective and as safe as continuous intravenous heparin given in-hospital. innohep (tinzaparin) has been shown to be safe and effective for both the initial and long-term treatment of dvt. the home lite study compares long-term innohep treatment to treatment with a combination of initial low-molecular-weight heparin followed by standard long-term warfarin therapy.

Eligibility criteria:
inclusion criteria: * patients having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy. exclusion criteria: * any condition which, in the opinion of the investigator, precludes entire out-of-hospital treatment * presence of familial bleeding diathesis or the presence of active bleeding contraindicating anticoagulant therapy * receiving therapeutic heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis * receiving long-term warfarin treatment * females who are pregnant * known allergy to heparin, warfarin sodium, or bisulfites * history of heparin-associated thrombocytopenia * severe malignant hypertension * hepatic encephalopathy * severe renal failure * inability to attend follow-up due to geographic inaccessibility * inability or refusal to give signed informed consent * mothers who are breast-feeding and who are unable to refuse to discontinue breast-feeding during study treatment
effectiveness of a structured intervention on the development of self-care behaviors with avf in hd patients

Conditions: Arteriovenous Fistula; Hemodialysis

Summary: end stage renal disease patients (esrd) should be educated to take care of their arteriovenous fistula (avf). educational programs should have clear objectives and the interventions should be well defined. therefore, assessing the interventions that can have the strongest impact on the patient's acquisition of self-care behaviors with avf is extremely important. the aim is to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with avf by patients with esrd on hemodialysis (hd).

this was a quasi-experimental study in dialysis units, involving patients using avf for hd. the dialysis units are located in the north of portugal (two units) and in the autonomous region of the azores (one unit). the study started after approval by the institution ethics committee. study setting and population the study was carried out in dialysis units the north of portugal, identified as control group (cg), and on an island in the autonomous region of the azores, identified as intervention group (ig). data collection and instrument all data were collected from january to june 2018. information concerning the sample demographic characteristics (age, gender, education, employment, marital status) and clinical characteristics (esrd etiology, dialysis vintage, previous avfs, avf duration, information on care with the avf) was collected with a questionnaire designed by the authors. information concerning self-care behaviors with the avf was collected from the scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (asbhd-avf) (8). this scale has 16 items in two subscales: subscale 1 - management of signs and symptoms (6 items) and subscale 2 - prevention of complications (10 items). responses to each item are based on a 5-point likert-type scale. higher scores show patients' higher frequency of self-care with the avf. the asbhd-avf scale has been applied to portuguese patients with cronbach's alpha of 0.797, 0.797 and 0.722 for the global scale and sub-scales 1 and 2, respectively. memory problems were assessed by the six-item cognitive impairment test (6cit), portuguese version (9).

Eligibility criteria:
inclusion criteria: * participants should be 18 years or older; * have an avf duration on hd greater than 6 months * have no memory problems * be medically stable. exclusion criteria: * patients with double vascular access (central venous catheter and avf) or grafts as vascular access * hospitalized patients at the time of data collection
efficacy, safety, and performance study of a novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.

Conditions: Fecal Incontinence

Summary: the purpose of this study is to evaluate the safety, efficacy, and functionality of the consure 120 stool management system in hospitalized bedridden patients suffering from fecal incontinence.


Eligibility criteria:
inclusion criteria: * male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool. * non-ambulatory, hospitalized patients. * history of passage of at least 1 stool in 24 hours. exclusion criteria: * patients with suspected or confirmed rectal mucosal impairment or pathology. * patients with have undergone descending colon or rectal surgery within the preceding six months. * patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination. * patients suspected to have impacted stool or is suffering from constipation. * patients with confirmed pregnancy or suspected to be pregnant. * patients that have planned mri examination over the duration of the study. * patients who have suffered recent cardiac arrest within the preceding 3 months. * patients enrolled in another clinical study or clinical trial. * patients on oral or iv anti-coagulation (e.g., iv heparin drip, acetylsalicylic acid , plavix). subcutaneous heparin or low molecular weight heparin are acceptable).

Keywords: fecal incontinence, consure medical, semi formed stool, stool management system
efficacy of telerehabilitation based exercises in patients with bell's palsy

Conditions: Bell Palsy

Summary: the study will be carried out with volunteer patients who are diagnosed with bell's palsy and comply with the study criteria.the aim of the study is to compare the home pnf exercise program with video-based telerehabilitation and the conventional training program in terms of outcome measures in patients with bell's palsy lesions.

with the telerehabilitation program, it is aimed that patients can easily adapt to home exercise programs and be followed up remotely. in this way, the most effective treatment of the disease will provide the patient with both motor function gain and psychosocial gain. this study was planned to examine the effectiveness of telerehabilitation in patients with bell's palsy.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 - 65 years * being diagnosed with bell's palsy by a specialist physician * having a lower motor neuron lesion * non-traumatic cases * not having any other neurological deficits * having signed the consent form exclusion criteria: * situations that will prevent assessments or communication with the individual * bilateral involvement * having an operation for facial palsy * having an upper motor neuron lesion * neurological problems that would preclude evaluation and/or treatment.

Keywords: bells pasly telerehabilitation peripheral facial paralysis proprioceptive neuromuscular facilitation
a low-residue diet for bowel preparation

Conditions: Colon Polyp; Colorectal Adenoma

Summary: previous researches demonstrated that a prepackaged low-residue diet (lrd) could achieve better bowel preparation quality compared with a self-prepared lrd. however, up to now, there has been no widely acceptable standard of lrd for bowel preparation. moreover, these prepackaged lrd adopted in previous studies mainly consisted of traditional foods without further processing. recently, a prepackaged lrd for special medical purpose was specifically designed for bowel preparation. this trail was to compare the impact of the prepackaged lrd on bowel preparation for colonoscopy with self-prepared lrd by patients.


Eligibility criteria:
inclusion criteria: * patients whose age is between 18-65. * patients who have indications for screening, surveillance and diagnostic colonoscopy. * patients who have signed inform consent form exclusion criteria: * subjects who had known or suspected heart failure, stroke or renal failure; * subjects who had a history of colon surgery or inflammatory bowel disease; * subjects who patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons; * subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products; * subjects who had high risk factors for bowel preparation such as chronic constipation, body mass index (bmi) greater than 30 or bmi less than 18 kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week; * subjects who had participated in another interventional clinical trial in the previous 60 days; * pregnant or lactating women and those planning to become pregnant.

Keywords: bowel preparation polyp adenoma
efficacy and safety of sofosbuvir/velpatasvir fixed-dose combination (fdc) and sofosbuvir/velpatasvir fdc and ribavirin in participants with chronic genotype 3 hcv infection and cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) and sof/vel fdc and ribavirin (rbv) for 12 weeks in participants with chronic genotype 3 hepatitis c virus (hcv) infection and compensated cirrhosis.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * individuals with chronic genotype 3 hcv infection and compensated cirrhosis * individuals with or without hiv-1 coinfection key exclusion criteria: * history of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol * co-infection with active hepatitis b virus * laboratory results outside the acceptable ranges at screening * pregnant or nursing female * chronic liver disease not caused by hcv note: other protocol defined inclusion/exclusion criteria may apply.
vascular changes of patients undergoing laparoscopic radical prostatectomy

Conditions: Prostatic Neoplasms; Erectile Dysfunction Following Radical Prostatectomy

Summary: a study designed to evaluate vascular changes after radical laparoscopic prostatectomy using doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. the baseline study will be compared with the study one year after surgery.


Eligibility criteria:
inclusion criteria: * male patients with prostate cancer who underwent laparoscopic radical prostatectomy exclusion criteria: * patients who were not interested in their sexual function and refused to perform this study * patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.